NCT07470580Toboroz
Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism and Hypertension
Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism and Hypertension: a Multicentre Prospective Randomized Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jún. 11.
Rövid összefoglaló (regiszter, angolul)
Primary aldosteronism (PA) is characterized by hypertension, frequent hypokalaemia, and an inappropriately high aldosterone-to-renin ratio (ARR). Aldosterone-producing adenoma (APA or Conn syndrome) is one of the main causes of primary aldosteronism. Laparoscopic (LA) total-adrenalectomy or adenoma selective is an option to normalize or at least improve blood pressure (BP) control, hypokalaemia, and normalize the ARR. However, the reported result of surgery is around 50% of clinical cure rate with an overall complication rate of 5 to 14% whereas hormonal success reached around 95%. More recently, radiofrequency ablation (RFA) has been used for patients with primary aldosteronism and unilateral adenoma. Investigator Team assume that treatment of unilateral PA by RFA could achieve similar efficacy to treatment by LA, with potentially less adverse events, and could be a more cost-efficient procedure.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 134 (tervezett)
- Első benyújtás
- 2026. márc. 10.
- Kezdés
- 2026. jún. 5.
- Elsődleges befejezés
- 2030. jún. 1.
- Fő szponzor
- University Hospital, Toulouse
- Betegségek
- Magas vérnyomás
- NCT-szám
- NCT07470580
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 134
- 2026. jún. 5. és az elsődleges befejezés (2030. jún. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- refusal to undergo radiofrequency ablation or adrenal surgery
- person taking part or having taken part in other interventional research in the previous 6 months
Más betegség
- Cushing's syndrome or pheochromocytoma
- patient who has had a heart attack or stroke within the last 6 months
- allergy to iodine
Laborértékek
- double anti-platelet aggregation, coagulation disorders or patients treated with anticoagulant treatment that cannot be stopped
- renal insufficiency defined as a clearance of <30 ml/min
Életkor
- refusal to perform adrenal catheterisation if age > 35 years
Egyéb
- a negative lateralization of secretion on adrenal venous sampling
- presence of bilateral adrenal tumours
- contralateral or bilateral macronodular adrenal hyperplasia
- no documented primary aldosteronism
- adrenal tumour > 4 cm
- contraindication to anaesthesia
- excessive proximity to sensitive adjacent organs
- minors and patients under guardianship, curatorship or safeguard of justice
- Inability to speak, read or write French fluently
- patients who refuse follow-up
- pregnant women or women wishing to become pregnant in the short term; breast-feeding
- any other relevant exclusion criteria as determined by the investigator
Kiket keres a vizsgálat
- Patient over 18 years of age
- Hypertension confirmed into the previous 9 months by ABPM 24h SBP/DBP >130 and/or/80 mmHg and/or diurnal SBP/DBP > 135 and/or 85 mmHg and/or nocturnal SBP/DBP >120 and/or 70 mmHg with or without antihypertensive treatment
- Diagnosis of primary aldosteronism confirmed by hormonal assays no more than 1 year before inclusion
- Presence of a unilateral adrenal nodule <4 cm considered suggestive of a Conn's adenoma on an prior adrenal CT or MRI scan, no more than 1 year before inclusion
- Adrenal venous sampling if age > 35 years (and according to investigator decision if age <35 years) to look for a lateralization of secretion: cannulation was successful when adrenal/peripheral venous cortisol gradients>2 and lateralization was assessed by comparison of right and left adrenal venous aldosterone/cortisol ratios with a cut off value>4 ipsilateral to the nod side to define a positive lateralization of secretion (2) no more than 1 year before inclusion
- nodule accessible to RFA according to the judgement of the interventional radiologist performing radiofrequency before randomisation
- nodule accessible to surgery
- patient willing to return for 6-month follow-up
- adult patient able to read the information sheet and give consent to take part in the study
- Patients affiliated to the French Health Insurance
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University Hospital of Toulouse | Toulouse | Franciaország | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.